← FDA DRUG APPROVALS

FDA ANDA · ANDA080975

RESERPINE

Sponsor: HIKMA INTL PHARMS

APPLICATION
ANDA080975
TYPE
ANDA
ORIGINAL APPROVAL
1972-12-26
LATEST ACTION
1991-02-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

RESERPINEDiscontinued
RESERPINE 0.25MG · TABLET · ORAL
RESERPINEDiscontinued
RESERPINE 1MG · TABLET · ORAL
RESERPINEDiscontinued
RESERPINE 0.1MG · TABLET · ORAL

Approval history

1991-02-08Manufacturing (CMC) · Supplement 16AP
1984-10-03Manufacturing (CMC) · Supplement 9AP
1982-04-06Manufacturing (CMC) · Supplement 7AP
1972-12-26OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA enforcement & recalls

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →